BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 2006658 · Received March 3, 2011

    Report

    Report Number
    2939301-2011-01841
    Event Type
    Injury
    Date Received
    March 3, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 21, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) # IS K072543. LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6) 2011 ALLEGING INACCURATE HIGH READINGS ON HIS ONE TOUCH SELECT METER. THE PATIENT MENTIONED THAT HE OBTAINED A 436 MG/DL, 436 MG/DL AND 466 MG/DL ON THE LFS METER. LESS THAN 30 MINUTES LATER HE TESTED ON ANOTHER METER AN OBTAINED A 356 MG/DL, 309MG/DL AND 361 MG/DL. THE PATIENT DID NOT TAKE ANY ACTION AFTER THE ALLEGED ISSUE BEGAN. AN HOUR AFTER THE INACCURATE READINGS, THE PATIENT FELT SHAKY. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT HIS PHYSICIAN FOR ASSISTANCE. WHILE TROUBLESHOOTING, IT WAS NOTED THAT THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT AND THE METER WAS MISCODED. WHEN A METER IS MISCODED AND USING AN INCORRECT TECHNIQUE IT MAY LEAD TO FALSE BLOOD GLUCOSE READINGS. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE HIGH READING, HE LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT SELECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2996852

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening